Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Acronym

Study hypothesis

Polysomnographic parameters in patients with obstructive sleep apnoea are influenced by the type of surgery and the type of anaesthesia.

Ethics approval

Ethics approval received from the Charité - Berlin Medical University Ethics Committee on the 18th May 2006 (ref: EA1/016/06).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Obstructive sleep aponea

Intervention

Group 1: 20 patients with surgery with general anaesthesiaGroup 2: 20 patients with surgery with regional anaesthesiaGroup 3: 20 patients with surgery on the upper airway with general anaesthesia

Randomisation of participants will be carried out between groups 1 and 2. There is no randomisation in group 3.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Apnoea-hypopnoea index, based on the following: 1. Continuous polysomnographic measurement. This will be carried out at the following timepoints:1.1. The night before surgery from 23:00 pm to 7:00 am1.2. For 2 hours in the recovery room after extubation1.3. After returning from the recovery room to the ward, until 7:00 am next day 2. The patients will be asked to rate the intensity/recreative power of the night sleep on a scale, from 1 (not recreative) to 5 (very recreative) the first and second morning 7:00 am

Secondary outcome measures

1. Patient satisfaction, based on the following: 1.1. The patients will be asked to rate his contentedness with the anaesthesia on a scale, from 1 (very content) to 5 (not content) the next morning after surgery1.2. The patients will be asked to rate the pain on a scale from 0 (no pain) to 10 (strongest pain) at the following timepoints:1.2.1. At the beginning of the anaesthesia1.2.2. Immediately after extubation1.2.3. After the first hour in the recovery room1.2.4. After the second hour in the recovery room1.2.5. Next morning after surgery2. Heart rate and blood pressure, measured as part of the continuous polysomnographic measurement (see primary outcome measures)3. Circulating mediators 4. Validity of screening

Overall trial start date

01/07/2006

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Obstructive sleep apnoea (the Epworth Sleepiness Scale [ESS] score greater than 9) 2. Elective surgery with either general or regional anaesthesia, or airway surgery 3. Aged greater than 18 years, either sex4. American Society of Anaesthesiologists (ASA) classification I - III